1. Inhibition of Crystallization in Highly Loaded Drug Bilayer Topical Patch using Lipid-Based Cosolvent
Oktavia Eka Puspita, Alya Tastbitha Elok Kamila, Oktavia Rahayu Adianingsih, Adeltrudis Adelsa Danimayostu
Abstract
A topical patch with highly loaded drug may lead to instability by forming recrystallization and causing gritty and dry patch also has implications for the rate of drug absorption through the skin and patch adhesion strength. The idea of keeping the drug to be molecularly dispersed will prevent the drug from being recrystallized. In this research, the lipid-based cosolvent was used to dissolve the drug as well as to keep the drug molecularly dispersed. Sodium diclofenac was used in this research as a drug model to be loaded into the topical patch. The current study aimed to develop topical patch formula and to evaluate the effect of using lipid-based cosolvent in preventing recrystallization. The patch was prepared using solvent casting method. The evaluation of the effect of lipid-based cosolvents in preventing drug recrystallization was carried out using x-ray diffraction method. The result showed that the addition of lipid-based cosolvents to the highly loaded sodium diclofenac topical patch formulation was able to prevent crystallization after storage at room temperature for six days.
2. Experimental Design for the Formulation and Optimization of Phloroglucinol Mouth Dissolving Tablets
Lammari Narimane, Mimoune Nada Yasmine, Ouaret Amel
Abstract
The purpose of the present study was to prepare and evaluate Phlorogluinol mouth dissolving tablets using experimental mixture design. Ten different formulations were generated based on three types of disintegrants (croscarmellose sodium, crospovidone and microcrystalline cellulose) by using simplex lattice design with Minitab 1.6® software. Tablets were prepared by direct compression technique. The percentage of drug release at 5min, 30 min and the disintegration time were statistically analyzed to get the optimized formulation. Drug content, hardness, friability and mass uniformity were carried out on the optimum formulation as further experiments. Tablets containing the mixture of the three disintegrants provided the best release profile and the fast disintegration. The results of the quality control tests for the optimized formulation complied with the requirements of the European Pharmacopoeia 9.2.
3. Development and Evaluation of a Topical Gel Containing 0.1% Adapalene and 2.5% Benzoyl Peroxide for Acne Treatment
Ngan-Hanh-Thao Nguyen, Dang-Khoa Nguyen, Phu-Gia Tran, Le-Duy Ly, Minh-Tri Le, Minh-Quan Le, Van-Ha Nguyen
Abstract
The gel product that combines two active ingredients adapalene (AD) and benzoyl peroxide (BO) has been used for a long time with good acne effectiveness and is licensed in the treatment of moderate to severe acne. On the market today, there are a few acne products containing these two active ingredients, however, the formula and preparation process have not been announced. Therefore, the study was conducted to research and prepare a gel product that combines AD 0.1% and BO 2.5%. The study results show that the gel formulation uses excipients Simugel SMS88 (6%), propylene glycol (4%), glycerin (4%), sodium docusate (0.05%), poloxamer 188 (0.2%). ) and demineralized water (83.15%) for a soft, pleasant physical sensation when applied, equivalent to a famous product (named X, which has the same ingredients and contents) in terms of parameters such as thinness, release of active ingredients, in vitro permeability . The results of stability monitoring under accelerated conditions for 6 months showed that the gel product had no significant physical or chemical changes. The research has successfully built the formula and process of preparing a gel product that combines the two active ingredients. The research results can be applied in upgrading larger batch sizes and deployed in production in the future.
4. Batch Scale-Up and Impact of Process Parameters on Blend Homogeneity in Production of Bilayer Film-Coated Tablets Containing Extended-Release Indapamide and Immediate-Release Amlodipine
Duyen Thi My Huynh, Son Thanh Khuu, Ly Ngoc Hanh, Nguyen Duc Tuan, Thanh Dung Phan, Tran Van-Hoai Le, An Viet Tran
Abstract
This study aimed to develop and optimize a manufacturing process for bilayer film-coated tablets containing extended-release indapamide and immediate-release amlodipine besylate. The formulation process included dry mixing, final blending, bilayer compression, film coating, and quality and stability evaluations. Optimization of the dry mixing and final blending times was performed to ensure uniformity and reproducibility. For the 10,000-tablet batch, the indapamide layer was processed using a high-speed mixer for 7 minutes at 500 rpm paddle speed and 1500 rpm chopper speed, followed by 5 minutes of final blending in a cubic blender at 17 rpm. The amlodipine layer underwent both dry mixing and final blending for 5 minutes in the cubic blender. In scale-up to a 100,000-tablet batch, adjustments in mixer parameters were necessary for the indapamide layer, and an extended initial mixing time of 6 minutes was required for the amlodipine layer. The bilayer tablets were successfully compressed and film-coated, exhibiting consistent physical properties and quality attributes. Stability testing confirmed the robustness of the formulation and process. The optimized manufacturing process was found to be scalable, repeatable, and suitable for commercial production, ensuring the consistent quality of the final bilayer film-coated tablets.
5. Medicinal Plants as Powerful and Efficient Sources of Diabetes Treatment Compared to Medicinal Insulins : Case Study Dukagjin Region in Kosovo
Arber Dreshaj, Donika Veseli, Altin Dreshaj, Florim Bajraktari
Abstract
The use of medicinal plants is a promising resource for the treatment of diabetes in Kosovo. In traditional medicine, a healthy lifestyle is the best way to prevent diabetes. The research of the study is the treatment of diabetes mellitus type 1 and 2, the role of insulin therapy and an overview of the use of medicinal plants used in the treatment of diabetes.The method is based on the collection of data on the number of patients with DM type 1 and 2, obtained from the protocols of the Regional Hospital of Peja and Family Medicine Centers in the municipality of Dukagjin. Also, data on the treatment of patients with insulin were obtained from scientific research in medical journals published in academic databases such as: (Scopus Web of Science, Elsevier., etc.). Number of samples in the study 154 patients.Statistics show that the treatment of patients with insulin such as Linagliptin and Steglujan results in the adequate treatment of (87.5%) of patients. The lowest insulin failure rate of Glyxambi, Soliqua, Ertugliflozin and Xultofia is up to (70%) in some patients. Treatment of patients with phytotherapeutic medicinal plants such as: Rosa Canina, Viccinium Berrica, Urtica etc., the results show a better and higher treatment effect, ranging from (85.71% – to 91.43%). The use of medicinal plants for antidiabetic treatment has an advantage of (4.81%) compared to insulin treatment.The results of the study are really promising in finding the solution for the prevention of diabetes, especially the orientation of patients with DM, in the use of antidiabetic herbs.
6. Design and Evaluation of Repaglinide Nanosuspension for Oral controlled Drug Delivery System by using 3
2 Factorial Design
Sonali Vijaykumar Magdum, Pramodkumar Jaykumar Shirote
Abstract
The current work proposed a nanocrystal-based formulation to overcome the solubility issues of repaglinide. Using the lyophilization procedure, REP nanosuspension was successfully transformed towards solid form. To make also preserve REP nanosuspension, polyvinyl alcohol as well as Eudragit S100 were used as protectors. Lyophilization’s suitability for enhancing physical stability was assessed by considering important restrictions, such as the shape of solid dispersion, on the characteristics of nanosuspension. The generated nanocrystals’ solid-state characteristics were also evaluated. Process factors that were improved increased the polydispersity index, zeta potential, drug content, also average particle size. Selective cryoprotectants (lactic acid) were used to assess the lyophilization procedure as an appropriate solidification approach. With an average particle diameter of 317 ± 3.4 nm, PDI about 0.150, also zeta potential about -10.2 ± 0.85 mV, formulation remained stable throughout three months at 4°C. The generated nanosuspension’s discharge profile showed a cumulative release of over 92.23%, compared to 8.02% during the first ten hours with unprocessed medicine. These findings suggest that the new formulation successfully increases Repaglinide’s water solubility.
7. Improving Solubility and Dissolution Characteristics of Dapoxetine Hydrochloride Through the Liquisolid Compact Method
Nagineni Sudarshan Rao, Rama Rao Vadapalli, Brahmaiah Bonthagarala, Jalluri Charishma Vasavi, Mallabathula Meghana
Abstract
This study aimed to enhance the solubility and dissolution properties of Dapoxetine hydrochloride (DXH) tablets by using of novel method i.e., liquisolid compact technology (LCT). A total of 9 formulations of DXH tablets were prepared by using carrier materials like microcrystalline cellulose and coating materials like lactose, silica, and starch. In out of nine formulations Super disintegrants like cross povidone (CP) in F1–F4 and Cross Carmellose Sodium in F5–F9 added. All formulations were evaluated for both pre compressional and post compressional evaluation parameters. Based on the evaluation parameters, the F6 formulation exhibited superior dissolution characteristics compared to others, indicating enhanced solubility rates. In vitro dissolution studies showed significantly improved release rates for DXH tablets.X-ray diffraction (XRD) analysis revealed a reduction in crystallinity, further supporting enhanced dissolution. Scanning electron microscopy (SEM) confirmed uniform dispersion of drug particles in the optimized formulation, leading to improved drug release. The absence of notable interactions between the drug and excipients was confirmed via FTIR analysis, ensuring formulation stability. In conclusion, LCT effectively enhanced the dissolution rate of DXH, demonstrating its potential as a promising approach for improving poorly water-soluble drugs.
8. Formulation and Evaluation of Aegle marmelos Infused Anti-ulcerative Toothpaste
Vijaykumar T Pawar, Sanjivani D Mulik, Arya A Musale, Firoj A Tamboli, Dipak P Mali, Dinanath T Gaikwad
Abstract
Aegle marmelos, commonly referred to as Bael, is renowned for its therapeutic potential, largely attributed to its rich content of bioactive flavonoids such as anthocyanins and betacyanins. These phytoconstituents are associated with notable antioxidant and anti-ulcer effects, primarily due to their capacity to neutralize free radicals. This investigation focuses on formulating a herbal toothpaste incorporating Aegle marmelos fruit extract, with the aim of aiding in the prevention and treatment of oral ulcers. The research encompassed both the development and comprehensive evaluation of the toothpaste formulation. Key quality parameters assessed included physical appearance, pH, consistency, foaming ability, sharpness of abrasive particles, spreadability, moisture level, and volatile matter content; all essential for product performance and consumer acceptability. The antimicrobial efficacy of the herbal toothpaste was examined through zone of inhibition studies against oral pathogens such as Bacillus subtilis and Staphylococcus aureus. Furthermore, the antioxidant activity was assessed through the DPPH free radical scavenging method, a well-established and commonly employed technique. Quantitative analysis of flavonoids was also performed, given their crucial role in therapeutic effectiveness. Overall, the results demonstrated that the toothpaste enriched with Aegle marmelos extract possesses significant antioxidant and antimicrobial activity, supporting its potential use as a natural remedy for managing and preventing mouth ulcers.
9. Preformulation Studies of Bergenin: A Primary Step in Future Designing of Novel Drug Delivery System
Urvashi Sharma, Sanjay Jain
Abstract
Preformulation studies are an essential stage in drug development, focused on elucidating the physicochemical and pharmacokinetic characteristics of a drug candidate to inform formulation design. Bergenin, a naturally occurring C-glucoside derivative of gallic acid, demonstrates a diverse array of pharmacological properties, encompassing anti-inflammatory, hepatoprotective, antiviral, and antidiabetic effects. Nonetheless, the effective incorporation of bergenin into an appropriate drug delivery system requires an extensive preformulation analysis. This research work was done with an objective to investigate the preformulation assessment of bergenin to evaluate its solubility in different solvents, compatibility, and crystallinity. The structural elucidation was done using FTIR spectroscopy and the X-ray diffraction (XRD) analysis validated the crystalline characteristics of bergenin, indicating a possible requirement for amorphization or particle size reduction methods to improve dissolving rates. Compatibility studies of drugs and excipients utilizing Fourier-transform infrared spectroscopy (FTIR) determined appropriate excipients for stable formulation. The results underscore significant problems, including inadequate solubility and crystallinity, that necessitate resolution via sophisticated formulation techniques such as solid dispersions or nanoencapsulation.
10. Evaluating the Activity of
Momordica charantia (Bitter Gourd) Fruit and
Curcuma longa (Turmeric) Rhizome Extract as Anti-Hyperlipidemic Agents in Experimental Animals
Marwan I. Al-Zuhairi, Ashok K. Shakya, Nawfal A. Numan, Sadeq Jaafer Al-Tameemi, Mohammed Bashar Al-Qazzan
Abstract
Hyperlipidemia may lead to a defect of blood vessels that raises the risk of atherosclerotic disease. The heightened prevalence of atherosclerosis is often linked to higher blood cholesterol, triglycerides, and low-density lipoprotein levels. Objectives: To study the effects of extended consumption of dietary bitter gourd and turmeric extract on Triton WR 1339-induced hyperlipidemia in rats. Methods: Albino Wistar rats were divided into five groups (6 rats/group) and fed specific diets for 21 days: ad libitum control (A), atorvastatin (B; 10 mg/kg body weight), turmeric extract (C; 150 mg/kg body weight), bitter gourd extract (D; 150 mg/kg body weight), and paired-fed extract (E; 150 mg/kg body weight each extract). Results: Turmeric and bitter gourd extracts significantly reduce alanine transferase, aspartate aminotransferase, LDL cholesterol, triglycerides, and total cholesterol (p<0.05) compared to atorvastatin, potentially improving liver enzyme levels through antioxidant activity.
11. Analyzing Moringa Oleifera Extract’s Antidiabetic Effects with an Osmotic Pump Delivery System
Nehere S V, Bhise K
Abstract
The growing prevalence of diabetes necessitates novel therapeutic approaches that enhance both efficacy and patient adherence. This study examines the antidiabetic efficacy of Moringa Oleifera extract delivered via an osmotic pump system in a streptozotocin-induced diabetic rat model, hypothesizing that this advanced delivery mechanism improves bioavailability and extends the duration of pharmacological action. The formulation comprised Moringa Oleifera extract, quercetin, and several excipients. Experimental evaluations measured fasting blood glucose levels, bodyweight changes, and biochemical markers of hepatic and renal function, comparing the osmotic pump–based treatment group to standard diabetic controls. Statistical analyses will discern the significance of observed therapeutic benefits, thereby contributing to the evidence base for phytopharmaceuticals in diabetes management and underscoring the potential of osmotic drug delivery systems to enhance clinical outcomes.
12. Formulation Optimization and Characterization of Transdermal Patches of Luliconazole and Posaconazole by Response Surface Methodology
Vibha Saxena, Ruchi Khare Shrivastava
Abstract
In the present study the transdermal drug delivery system of two anti-fungal drugs i.e., luliconazole and posaconazole was reported using surface response method. Independent variable like HPMC, E-5 and PEG and dependent variable i.e., folding endurance and in vitro release study were taken in consideration. 15 formulations having varying concentration of polymers and permeation enhancer were formulated using solvent casting method. Results indicates that R1 (folding endurance) and R2 (% drug released) ranged from 62 to 88 and 76.22 to 92.46 %. Validated values were found to be much closed to the optimized values and results were closed to the selected batches as obtained by the software’s.
13. Design, Optimize and Evaluate Dapagliflozin Sustained Release Microspheres using Box-Behnken Design
Anushree Chauhan, Ganesh Prasad Mishra, Surbhi Gupta
Abstract
This study aimed on optimizing dapagliflozin microspheres for sustained release to improve efficacy over the marketed product. Microspheres were formulated by a Solvent Evaporation method involving sodium alginate, ethyl cellulose and HPMC K 100. The process was optimized through Box- Behnken statistical experimental model, adjusting polymer concentration, surfactant amount and rotational speed. Seventeen formulations were formulated and the optimized formulation (F2) was investigated for its micromeritic characteristics, SEM, in-vitro release, kinetic modeling, and stability. FT-IR study showed no negative correlation among the drug and polymers. F2 exhibited maximum yield (81.78%), entrapment efficiency (82.21%) with optimum particle size (278.69 μm). Increased concentration of polymer improved yield and efficiency of drug entrapment while stirring rate decreased particle size. SEM analysis revealed rough, porous and spherical microspheres, and the release was sustained, with 98.02% of the drug released over 20 hours. The optimized microspheres showed prolonged drug release under gastrointestinal conditions, offering increased efficacy and potentially enhancing patient adherence by lowering dosing compared to the marketed product.
14. Fabrication and Characterization of Novel Liquid Film Forming Solution for Pain Management
Nidhi Namdev, Mousumi Kar Pillai, Sujit Pillai, Prabhat Kumar Das
Abstract
The purpose of the current study’s is to develop, characterize, and analyze a novel transdermal film forming solution of Tramadol (TMD) in order to maximize drug availability, minimize the frequency of oral side effects, and eliminate the need for frequent dosing. Tramadol is an opiate pain reliever, used to treat moderate to severe pain caused on by both acute and chronic illnesses or injuries. They lessen pain by influencing your brain and nervous system. The preparation of Film Forming Solutions (FFS) for transdermal distribution of TMD involved the use of Eudragit-L100, Hydroxy-Propyl Methyl Cellulose (HPMC E5), and PVA as a film forming polymer, ethyl alcohol as a solvent, PEG 400 as a plasticizer. The pH, viscosity, drying time and drug content was assessed for FFS. They also underwent in-vitro drug release testing. For every test, every formulation produced results that fell within an acceptable range.The formulation F5 was determined to be the best based on the basis of physiochemical evaluation. Formulation gave 76.83% of sustained drug release within 10 hrs. It is further evaluated for SEM analysis and in vivo analgesic study. A film-forming solution formulation may be regarded as an acceptable approach for pain management because the developed formulation exhibited comparable analgesic activity to that of the commercially available traditional formulation.
15. Indomethacin-Loaded Nanosponges for Oral Delivery: Formulation Strategy, Optimization, and
In-vitro Evaluation
Vipulata P Galankar, Ganesh D Basarkar, Chandrashekhar D Upasani, Sunil V Amrutkar
Abstract
Chronic illnesses like arthritis cause pain and inflammation, requiring extended oral analgesic therapy. To reduce adverse reactions, active pharmaceutical ingredients are administered through sustained-release dosage forms. However, methods like matrix tablets, osmotic systems, and ion exchange resins have limitations. Nanotechnological approaches like nanosponges improve precision and accuracy in medication release manufacturing. Encapsulated formulations offer benefits like reduced side effects, varied dose options, non-irritating properties, and aesthetic appeal. Nanosponges are used in formulation to provide stability, improve bioavailability, alter taste, and target medication distribution systems. β-cyclodextrin-based nanoparticles are used to achieve active pharmaceutical ingredients characteristics. Polymers like ethylcellulose are commonly used for sustained-release formulations. Nanosponges can be synthesized using techniques like solvent technique, cross-linking, ultrasound-assisted preparation, and emulsion solvent diffusion. Ultrasound-assisted method is efficient and cost-effective. The study aims to develop indomethacin-loaded nanoparticles for a sustained-release tablet, obstructing prostaglandin synthesis, a chemical responsible for inflammation and discomfort. Indomethacin, a class II medication, is suitable due to its low solubility and molecular weight. This study developed and evaluated sustained release preparations of indomethacin-incorporated nanoparticles using EC as a polymer, analyzed physicochemical parameters, and developed a nanoparticle-loaded tablet dosage form.
16. Development of AuNPs-Based Gel: Physicochemical Properties, Antibacterial Activity, and Skin Permeation Studies
Jyoti Arsude, Machindra Chavan, Shriram Pethakar, Sumit Joshi
Abstract
Gold nanoparticles (AuNPs) have raise as versatile agents in biosciences applications due to their exclusive physicochemical nature. principle of this investigation is to formulate and test a gel containing AuNPs that uses Carbopol 934 as its gelling agent. To optimise the medicinal and rheological qualities, gels were made using different concentrations of carbopol (0.5%, 1.0%, 1.5%, and 2.0%), along with various excipients such as triethanolamine and black cumin oil. The physicochemical properties of the gels were assessed, including their homogeneity, transparency, pH, spreadability, viscosity, medication concentration, and ability to gel. Effective drug delivery was demonstrated in ex vivo skin permeation and deposition tests utilising rat abdomen skin. In comparison to commercial formulations, the AuNPs gel demonstrated substantial zones of inhibition when tested against methicillin-resistant Staphylococcus aureus (MRSA), Pseudomonas aeruginosa (PA), and Staphylococcus aureus (SA),. The formulations were found to be safe in skin irritancy testing. The outcomes of this study display that AuNPs gels have great promise as a safe and effective vehicle for transdermal drug administration with improved therapeutic efficacy and less discomfort.
17. Studies on Spectral Characterization, Dissolution and Solubility of Aceclofenac Multicomponent Inclusion Complex Using Different Auxiliary Agent
Patil P A, Kumbhar S T
Abstract
Current research was designed to examine how aceclofenac interacted with cyclodextrin and its derivatives. The different auxiliary agents such as mannitol, L-arginine and citric acid were also evaluated for enhancement solubility of aceclofenac and selected as third component for preparing multicomponent inclusion complex. In direction to increase bioavailability and solubility of the poorly soluble medication aceclofenac, a complex was created that belongs to BCS CLASS-II. The multicomponent inclusion complex was created by using physical mixing and kneading techniques. The distinct concentrations of L-arginine were tested for the ternary systems. Interactions between the solid and liquid phases were studied using FTIR, DSC, XRD, and 1H-NMR. A study on phase solubility proved that L-arginine significantly affected the methyl-β-cyclodextrin complexation with aceclofenac. Saturation solubility study and in-vitro study state that prepared complex shows expansion of solubility similarly bioavailability of poorly water-soluble aceclofenac.
18. Retrospective Analysis of Guillain-Barré Syndrome: A Pharmaceutical Perspective
Snehal Gojare, Sumit Deore
Abstract
One of the most common causes of flaccid paralysis, Guillain Barre Syndrome (GBS) has long been a major health problem around the world. Substantial evidence supports the autoimmune nature of this syndrome, with the autoantibody profile playing a crucial role in confirming the clinical and electrophysiological associations between GBS and various other peripheral nerve disorders. This research is aimed to assess the clinical features, electrophysiological, treatment pattern and functional outcome of a multi-centre cohort of GBS patients. Tertiary care hospitals in the Maharashtra region of India were the focus of the present retrospective observational cohort study. Data for the GBS cases admitted during June 2018 to Dec 2023 were included for the current study. Data collected were included clinical features, reported electrophysiological data, treatment and outcome. All the data were assessed with the help of statistical models. The study comprised a total of 25 participants diagnosed with GBS. Males made up the vast majority of the GBS patients (72%). An average age at presentation was 44 ±13 years. The symptom that present most frequently was ascending or upward paralysis that happened in 20 patients (80%). The remaining common symptoms were sensory disturbances (40%), bladder and bowel complaints (28%) and difficulty in up-squatting. In this cohort analysis, COVID-19 infection was the most common antecedent event (44%). All the patients administered GBS-specific therapy of whom 84 % patients had given Intravenous Immunoglobulin (IVIG) along with Antibiotics, 12% of patients had given Plasmapheresis treatment along with IVIG and 4% of patients had given IVIG, Antibiotics, Plasmapheresis and ventilator. According to this research the maximum number of patients had a favourable functional outcome, i.e. 92% and 8% patients showed poor functional outcome.
19. Drug Repurposing for Vancomycin-Resistant
Enterococcus faecalis (V583): A Structure-Based Virtual Screening Approach
Sanjivani Panditkar, Machchhindra Holam, Satish Dhonde, Tushar Fegade
Abstract
Bacterium Enterococcus faecalis that has shown resistance against Vancomycin (V583) happens to pose serious threats on the clinical front as it is resistive to the last line of antibiotics drugs. This study looks like a structure-based virtual screening of the predicted inhibitors for AhpF C503A mutant form of the bacteria E. faecalis. Such refinement would improve a model that uses the PDB-REDO server which brings down R-free from 22.1% to 19.6% while improving stereochemical accuracy. The refined structure was validated for computational screening by using ProSA, Ramachandran plot analysis, and Verify3D. The receptor-based virtual screening from DrugRep FDA approved drug identified the following compounds with high binding affinity as top-three candidates: Venetoclax (-10.2 kcal/mol), Rimegepant (-9.7 kcal/mol) and Lumacaftor (-9.5 kcal/mol). Key interactions consist of hydrogen bond formations and hydrophobic contacts, as evidenced by the molecular docking analysis within these active sites. Such findings provide potential drug repurposing candidates for E. faecalis infections and part of the foundation for further molecular dynamics simulations and experimental validation.
20. Design and Evaluation of Tenofovir Alafenamide-Loaded Solid Lipid Nanoparticles Gel for Enhanced Transdermal Delivery
Ashish B Wadekar, Samir Atara, Dipak D Kumbhar
Abstract
This research essentially examines the design and evaluation of a gelling agent for transdermal delivery enhancement of Tenofovir Alafenamide (TAF)-loaded solid lipid nanoparticles (SLNs). Pre-formulation screening proved the drug is pure with a λ max 260 nm and a calibration curve (R² = 0.9999) for quantifying it. TAF-loaded SLNs showed a particle size distribution between 125.8 ± 2.0 nm to 274 ± 2.5 nm, with a PDI of 0.192 ± 0.04 to 0.214 ± 0.06 and zeta potential of -18.2 ± 4.1 mV to -26.6 ± 3.2 mV, denoting ideal characteristics for stability and drug delivery. Formulation optimization of SLN was carried out with 96.42% entrapment efficiency. The TAF-loaded SLN-gel is characterized by a homogeneous texture, adequate smoothness, and has pH values in the range of 6.02 to 6.15; during the ex-vivo permeation study, it was found that the cumulative TAF permeation over 24 h was 45.2 µg/cm². In vitro drug release data showed sustained release for 12 hours and a cumulative drug release at 71.4%. The gel showed good spreadability (7.2 cm) and extrudability (4.8-5.5 N) and minor variability over a period of 3 months. Acute dermal toxicity and skin irritation assessments were carried out and exhibited no significant side effects. The Primary Irritation Index (PII) of 0.44 classified it as a mild irritant. Therefore, it can be legitimately stated from the studies that the TAF-loaded SLN gel can be developed into a potential transdermal drug delivery system with sustained release characteristics, excellent entrapment efficiency, and good safety profiles.
21. Network Pharmacology and Molecular Docking Studies to Explore Mechanistic Insights of Bonnisan, used for Treatment of Infantile Colic
Deshraj Chumbhale, Pankaj Chaudhari, Ashwini Shelke, Lokesh Barde
Abstract
Infants with infantile colic, a common gastrointestinal condition, wail uncontrollably and in a painful manner. The molecular mechanism of action of the Ayurvedic proprietary compound bonnisan, which has been used traditionally to improve infant digestion, has not yet been fully studied. Therefore, this study intended to investigate the mechanism of action of Bonnisan in infantile colic utilizing network pharmacological and molecular docking techniques. Bonnisan’s active phytoconstituents were found in online databases and literature. KEGG-pathway analysis, genes ontology (GO) enrichment, proteins-protein interactions (PPI) analysis, and network pharmacology were used to predict the target. Additionally, studies using molecular docking were conducted to investigate ligand-target interaction. A total of 62 bioactive compounds and 85 potential targets were yielded, out of which major proteins such as PTGS2, NOS2, TNF, and HTR3A were found to be closely associated with coindexing colic-related inflammation, pain modulation, and gut motility. For KEGG pathway analysis, the enrichment in pathways that were significant included PI3K-Akt signaling, neuroactive ligand-receptor interaction, serotonergic synapse, and inflammatory pathways related to the pathophysiology of colic. Molecular docking results demonstrated strong binding of ligands to targets: oleanolic acid (-9.2 kcal mol-1, PTGS2), ursolic acid (-8.7 kcal mol-1, TNF) and linalool (-7.5 kcal mol-1, HTR3A) were the major bioactive compounds for the observed changes. The study mechanistically explains the effects of Bonnisan’s multiple-target pharmacological activities in managing infantile colic, most notably with anti-inflammatory, gut motility regulation, and neuromodulatory actions. These computational predictions require more experimental validation and eventually enhance their clinical applicability.
22. Repurposing of Nemiralisib as a Potential CDK4 Inhibitor for Breast Cancer Treatment: A Ligand-Based Virtual Screening and Docking Study
Pankaj Jadhav, Godfrey Mathews, Aaditya Chayani, Surekha Salgar
Abstract
As part of the drug repurposing efforts, a pliable PI3K inhibitor Nemiralisib that was developed for use in respiratory diseases was studied for her potential use as a new CDK4 inhibitor in the treatment of breast cancer. Utilization of ligand based virtual screening and molecular docking studies further revealed an appreciable binding affinity of Nemiralisib to CDK4 with a docking score of – 11.1 which is markedly similar to that of an already established CDK4/6 inhibitor, Abemaciclib (-11.5). From structural studies, it was clear that Nemiralisib binds to the CDK4 binding pocket using several residues such as GLU11, ILE12 and ASP97 in a way similar to how Abemaciclib does. Moreover, additional synergy prediction studies using the PISCEScsm platform anticipated the effects of the combination, especially in breast cancer of Nemiralisib with Fulvestrant and Tamoxifen to be more than additive. All these data support the idea that Nemiralisib may be a useful drug to add to the treatment of hormone receptor-positive breast cancer and improve currently existing therapies. This study opens doors of using Nemiralisib in the field of oncology, with an encouraging avenue of treatment for breast cancer patients.
23. Enhanced Antifungal Efficacy of Clove Oil using Nanosponges: A Novel Topical Delivery System
Anuradha Salunkhe, Smita More, Shashikant Dhole
Abstract
Clove oil (CO), derived from Syzygium aromaticum, is recognized for its broad-spectrum antimicrobial, antifungal, and anti-inflammatory properties. Still, its pharmaceutical uses are narrow due to poor aqueous solubility, chemical instability and potential skin irritation. This study aimed to enhance CO’s therapeutic efficacy using nanosponges as a novel delivery system. A 3² complete factorial design was used to optimise the synthesis of ethyl cellulose nanosponges, which were achieved utilising the emulsion solvent diffusion method. optimized formulation (F4) exhibited high entrapment efficiency (94.38%) and practical yield (93.23%). The nanosponge-loaded gel exhibited excellent physicochemical properties, including a pH of 5.4, viscosity of 13,092 cps, and sustained drug release (92.3% over 12 hours) following zero-order kinetics. In vivo studies in an immunosuppressed rat model of Candida albicans infection exhibited significantly improved antifungal efficacy with the nanosponges-loaded CO gel compared to pure CO gel. Histopathological analysis confirmed enhanced skin recovery, while the Draize patch test indicated no skin irritation. Stability studies further validated the formulation’s long-term integrity, with consistent drug release over 90 days. The results suggest that nanosponges-based CO delivery enhances antifungal activity, improves bioavailability, and minimizes skin irritation, making it a promising approach for topical antifungal therapy.
24. Formulation, Optimization and Characterization of Ticagrelor Loaded NLCs Formulation
Ahire Sujeetkumar Ishwarlal, Gupta Revathi A
Abstract
Ticagrelor is a P2Y12 inhibitor for cardiovascular issues and it works by preventing platelet aggregation, thus reducing the risk of thrombotic events. ticagrelor has shown potential benefits in rheumatoid arthritis when combined with methotrexate. Ticagrelor’s role in reducing cardiovascular events may be beneficial for patients with rheumatoid arthritis who are at increased risk for cardiovascular issues. The present study was aimed to formulate, optimize and evaluated ticagrelol loaded NLCs using Box-Behnken design was used. The design was implemented to statistically optimise the factors that were independent: drug: lipid ratio (X1), the surfactant concentration (X2), and soy lecithin concentration (X3), as well as to investigate the main effect, interaction effects, and quadratic effects of these formulation-ingredients on the dependent (response) factor: Entrapment Efficiency (Y1) and in-vitro% drug release (Y2). The independent variables and by combining the above components in variable concentrations (levels), 14 batches were created and evaluated based on the response.
25. Formulation and Development of Solifenacin Succinate Oral Suspension
Prashant Deore, Jayesh Dwivedi
Abstract
Solifenacin succinate is prescribed for patients with overactive bladder (OAB) syndrome to address symptoms such as urge incontinence, increased urinary frequency, and urgency. Tablet formulations can be challenging or impossible to administer to patients who are unable or unwilling to swallow solid dosage forms like tablets or capsules. For these patients, a liquid formulation of Solifenacin succinate is a more suitable alternative. The goal was to develop a liquid formulation with reduced astringency and bitterness compared to Solifenacin succinate in its raw form, while ensuring good drug content homogeneity. A Solifenacin succinate suspension was developed and evaluated based on parameters including pH, density, viscosity, % assay, and drug release profile. Batch optimization was carried out using design of experiment (DoE) software. The optimized formulation was subjected to stability studies as per ICH guidelines. Trial batches played a crucial role in formulating the suspension. Suspending agent (MCC/CMC sodium), viscosity modifier (Xanthan gum) and sweetener (Xylitol) were considered as independent variables and viscosity, dissolution and content uniformity, the suspension batch was optimized with a desirability score of 0.63 using DoE software. The optimized batch demonstrated stability and successfully passed the stability tests. A stable oral suspension dosage form of the anti-muscarinic drug Solifenacin succinate was successfully developed, meeting pharmacopoeial standards and offering a patient-friendly alternative for those with difficulty swallowing solid dosage forms.
26. Sugar-Phosphate Composite Glasses for Lysozyme: An Effective Technique for Lysozyme Preservation
Sanjay Lade, Jayesh Dwivedi
Abstract
The Spray drying method was employed for the processing and storage preservation of lysozyme using sugar-phosphate glasses. While previous studies have reported the surfactants to reduce protein adsorption at the air/water interface, this study demonstrates that water-soluble inorganic phosphates effectively minimize lysozyme surface adsorption. Sugar glasses containing sucrose or mannitol, combined with water-soluble phosphates and glass formers such as PVP K30 or calcium lactate were prepared using hot plate drying. These sugar glasses were evaluated to confirm their glassy state using optical microscopy, infrared spectral analysis, X-ray diffraction (XRD), and thermal behavior studies (DSC). The lysozyme mixtures with sugar glasses were processed using both spray drying and lyophilization. They were then analyzed for pH, moisture content, % yield, and % lysozyme activity. Physical changes in lysozyme were assessed using XRD. The batch exhibiting the highest lysozyme activity was selected for stability testing in accordance with ICH guidelines. Results indicated that water-soluble phosphates, in combination with glass formers like PVP K 30 and calcium lactate, efficiently formed composite glasses during spray drying, whereas water-insoluble phosphates failed to produce a stable glassy matrix. XRD analysis of sodium phosphate monobasic and dibasic in the presence of glass formers confirmed an amorphous state during post-stability studies, with maximum lysozyme activity retained at room temperature. The processing and storage stability of lysozyme was superior in spray-dried products compared to lyophilized ones. These findings validate the potential of sugar-phosphate composite glasses as an effective technique for lysozyme preservation, offering a promising approach to enhancing protein stability in pharmaceutical formulations.
27. Application of Sustainable Microbial Techniques in Biomonitoring for Environmental Sustainability
Archita Tiwari, Bharat Mishra, Bhupendra Singh, Shrishti Mishra
Abstract
The growing rates of pollution have been driving global warming, rising sea levels, and species extinction, impacting both developed and developing nations alike. Traditionally, chemical analysis of air, water, and soil was employed to detect pollutants. However, by the time harmful chemicals were identified in these environments, significant damage had already occurred, making remediation efforts challenging. Bioindicators refer to living organisms like plants, animals or microbes which mirror the changes in environment composition due to pollution. Monitoring species or organisms which are very sensitive to such environmental changes constitute biomonitoring. For these techniques such as PCR, microscopy, immunological assays, biosensors, and microfluidics are crucial for environmental sustainability. PCR detects microbial contaminants and assesses biodiversity, while microscopy identifies and monitors microorganisms. Immunological assays like ELISA and EIA detect specific toxins and track environmental changes. Biosensors offer real-time pollutant data, lateral flow assays provide rapid on-site testing, and microfluidics enable efficient, high-throughput analysis. ELFA offers high sensitivity for trace pollutants, and other serological assays help identify pathogens and assess pollution impacts, collectively improving pollution monitoring and ecosystem health. The effect of environmental pollutants reflects in the lower levels before it occurs in higher levels. Lower levels include cellular, molecular and physiological changes that occur as a result of pollution and known as biomarkers, which act as an early warning system for toxic pollutants. Microbial communities present in air, water and soil are one of the early bioindicators used for assessing the pollution levels. Evaluation methods include detecting, tracking and quantifying microbes; monitoring diversity indices of microbial communities and analysing specific metabolic pathways. Biomonitoring techniques include high-throughput sequencing, quantitative Polymerase Chain Technology, metaproteomics, metatranscriptomics and metagenomics. Cultivable microbes are commonly used but cultivation independent methods like pathogen tracking and toxin tracking needs to be included for an accurate picture. Integrating biological methods with technology like bioinformatics and machine learning tools could increase the efficiency of biomonitoring using microbes.
28. Development and Characterization of Modified Release Dosage Form Utilizing Semaglutide
Aanchal Dangi, Komal Sharma
Abstract
An agonist of the glucagon-like peptide-1 (GLP-1) receptor, semaglutide, when administered as a pure medication solution, has a significant degree of variability in bioavailability due to its low solubility and low permeability. This variability is reflected in the wide range of plasma concentration values (5.85–38.14), affecting its therapeutic effectiveness. The present study aimed to develop and characterize a modified-release dosage form (FPR-8) to enhance the pharmacokinetic profile of Semaglutide by ensuring controlled and sustained drug release over 24 hours, thereby reducing fluctuations in plasma concentration and improving bioavailability. The optimized formulation FPR-8 was developed and evaluated for its drug release profile, pharmacokinetic parameters, and in vivo performance in animal models. The improved formulation’s plasma concentration values were contrasted with those of a pure drug solution. Administration of FPR-8 resulted in significantly reduced variability in plasma concentration values (4.12–19.46) compared to the pure drug suspension. The controlled-release formulation facilitated slow and gradual absorption, ensuring prolonged systemic circulation of Semaglutide over 24 hours. This sustained-release effect contributed to enhanced bioavailability and reduced fluctuations, addressing the limitations associated with the pure drug’s pharmacokinetic profile. The development of a modified-release dosage form (FPR-8) successfully optimized the pharmacokinetic behavior of Semaglutide, ensuring consistent absorption, prolonged circulation, and reduced intersubject variability. This approach holds promise for improving therapeutic efficacy and patient compliance in the clinical use of Semaglutide.
29. Estimation of Added Urea in the Food Products and Marketed Formulation using 1,2-Napthoquinone-4-Sulphonate Reagent by UV- Visible Spectrophotometer
K Bhavya Sri, T Bhagyasri, Dhilli Rao Gorja, C A Sri Ranjani, P Sandhya
Abstract
Milk naturally contains urea, which makes up a large portion of the amount of non-protein nitrogen found in the milk. The amount of urea in milk varies throughout herd members. Following that, urea and the Folin (NQS) solution mix to form a vibrant complex that is visible as an absorbed range of 454 nm. Following optimization, the limit of detection and quantification limitation were found to be the optimal experimental variables, at 0.00280 and 0.00848 µg/ml, respectively. The calibration plot for urea shows a straight line in a concentration that ranges from 0.1–10 µg/mL. The coefficient of the determination was R2 = 0.9999.
30. Development and Evaluation of Dispersible Tablet comprising Tenofovir, Bictegravir and Emtricitabine
Nitin Mehetre, Inderbir Singh
Abstract
Maximum Anti-HIV Drugs Dosage Forms are available as tablets or capsule dosage forms. Such Dosage Forms are not suitable for patient who is having difficulty to swallowing. Antiretroviral therapy for treatment of HIV Infection contains more than two drugs so dose of drugs are more and most of these drugs are having issues like high bitterness, low solubility, highly moisture sensitivity and drugs incompatibility issue so to formulate HIV drugs into dispersible tablet is challenging. In present research, fixed dose combination of Tenofovir, Bictegravir and Emtricitabine were used to formulate the dispersible bilayer tablet. Bictegravir sodium is BCS class II drug hence with this drug eight different formulation for solubility enhancement was performed. All the physicochemical parameters were evaluated for the granules, Dissolution, assay for the granules were determined. For second layer of Tenofovir, and Emtricitabine, disintegrant concentration was optimized with three different formulations and evaluation was done like flow properties of granules, DT, assay and dissolution. All the results were compared with the marketed product. The formulation F10 showed desirable DT, assay, and dissolution hence it was selected as best formulation.
31. Phytochemical Analysis and Anti-Urolithiatic Potential of
Cyamopsis tetragonoloba and
Trichosanthes dioica
Mayank Kumar, Rupali Sharma, Vimal Kumar Yadav
Abstract
Objective: The medicinal and industrial uses of plants have long been acknowledged. Bioactive chemicals, nutritional advantages, and pharmacological characteristics are what make Cluster Bean (Cyamopsis tetragonoloba) and Pointed Gourd (Trichosanthes dioica) so special. The purpose of this research is to determine whether or not they have anti-urolithiatic properties and to examine their phytochemical makeup. Materials and Methods: After collecting and verifying the plant materials, they were extracted using the Soxhlet apparatus and solvents such as petroleum ether and ethyl acetate. To find the most important bioactive chemicals, phytochemical screening was performed. For the purpose of phytochemical profiling, HPTLC and Thin Layer Chromatography (TLC) were employed. The anti-urolithiatic action was assessed in Wistar rats that had hyperoxaluria induced by ethylene glycol. Lactate dehydrogenase (LDH) activity, kidney oxalate levels, and urine parameters were examined. Results: Essential oils, glycosides, tannins, flavonoids, and saponins were all identified through phytochemical research. In terms of extraction efficiency, ethyl acetate extract outperformed petroleum ether. Several bioactive substances were found through chromatographic analysis. Treatment groups showed markedly enhanced renal function and reduced oxalate deposition in in vivo investigations, suggesting substantial anti-urolithiatic activity. Conclusion: The study highlights the potential use of C. tetragonoloba and T. dioica in nutraceutical and pharmaceutical applications by establishing their pharmacological relevance. To learn more about how effective they are as a treatment, additional studies involving clinical trials and formulation development are needed.
32. Multicomponent Crystal of Aceclofenac with Saccharin to Improve Solubility and Dissolution
Rate
Hendrizal Usman, Yufri Aldi, Salman Umar, Muhammad Nasrul Siregar, Erizal Zaini
Abstract
Aceclofenac is a Non-Steroidal Anti-Inflammatory Drug (NSAID) frequently prescribed for managing osteoarthritis and rheumatoid arthritis. It is categorized under the Biopharmaceutics Classification System (BCS) as a Class II compound, characterized by low water solubility but high membrane permeability. This poor solubility presents challenges in dissolution and absorption in gastrointestinal fluid. The objective of this study was to improve the solubility and dissolution behavior of aceclofenac by formulating a multicomponent crystal with saccharin as the selected coformer. The multicomponent crystal was prepared through a solvent-drop grinding technique using a 1:1 molar ratio. To confirm the formation and evaluate the physicochemical properties of the multicomponent system, solid-state characterization was performed using differential scanning calorimetry (DSC), powder X-ray diffraction (PXRD), and Fourier-transform infrared spectroscopy (FTIR). Additionally, solubility and in vitro dissolution tests were carried out and compared with those of the unmodified drug. Results from DSC and PXRD demonstrated a substantial decrease in crystallinity, evident by the loss of distinct melting peaks and diffraction signals, indicative of eutectic formation. This structural alteration is associated with a reduction in lattice energy, which contributes to enhanced dissolution. FTIR spectra verified the absence of covalent interactions between the drug and coformer. The optimized multicomponent crystal exhibited a 2.49-fold increase in solubility and a 2.6-fold enhancement in dissolution rate relative to pure aceclofenac. Overall, this study supports the use of multicomponent crystal engineering with saccharin as a feasible approach to improve the biopharmaceutical performance of aceclofenac.
33. Effect of Vortioxetine on Pilocarpine Induced Status Epilepticus in Sprague Dawley Rats
Shreya Hegde, Sharath Kumar C, Amrita Parida, Jagnoor Singh Sandhu, Manju V
Abstract
Background: Status epilepticus (SE) is a frequently encountered medical emergency that may not respond to existing antiepileptic medications, underscoring the urgency for exploring alternative treatment options. Vortioxetine, a novel multimodal antidepressant, modulates several serotonin receptors and has shown anticonvulsant potential in other seizure models. However, its role in SE remains unexplored. Objective: The study assessed the impact of vortioxetine on seizure severity, onset latency, and 24-hour survival in a rodent model of status epilepticus using lithium-pilocarpine. Methods: Twenty-four male Sprague Dawley rats were randomized into four groups: (1) disease control (distilled water), (2) standard treatment (diazepam, 5 mg/kg), (3) vortioxetine 10 mg/kg, and (4) vortioxetine 20 mg/kg. All groups received lithium chloride and pilocarpine to induce SE. Modified Racine scale was used to score the seizure severity. Latency to stage 4 seizures and SE, seizure scores, and 24-hour survival rates were assessed. The mean differences between groups was analyzed by one-way ANOVA. This was followed by Tukey’s post hoc test to see the intergroup differences. Results: All animals in the disease control and low-dose vortioxetine groups progressed to stage 5 seizures and SE, with 33.3% and 16.7% mortality, respectively. In the high-dose vortioxetine group, 83.3% developed SE with no mortality. Diazepam significantly delayed seizure onset, reduced severity, and prevented SE. Vortioxetine at both doses showed only marginal increases in seizure latency and no significant reduction in seizure severity or SE incidence compared to control. Conclusion: Vortioxetine did not exhibit significant protective effects against lithium-pilocarpine-induced SE in Sprague Dawley rats at the doses tested. Its limited efficacy may be due to the complex pathophysiology of SE and the acute nature of the model. Further studies are warranted to explore its role in chronic epilepsy models or as adjunctive therapy.
34. 4-Hydroxyisoleucine-Loaded Nanogel: Development from an Optimized Nanoemulsion for Antidiabetic Therapy
Naresh Kumar, Garima Gupta, Amit Singh, Rakesh K Sindhu, Mohammad Rashid
Abstract
This work focuses on the creation and assessment of a nanogel system produced from an optimal nanoemulsion formulation infused with 4-hydroxyisoleucine, a powerful antidiabetic bioactive agent. Diabetes mellitus affects 425 million people globally, with 82 million in Southeast Asia. The pandemic could lead to cardiovascular disorders, strokes, renal failures, and blindness. Fenugreek has anti-diabetic properties and reduced cholesterol levels in type II diabetes patients. Nano-carriers improve drug bioavailability. Method: Nanoemulsions were created with an aqueous titration emulsification technique and tailored according to droplet size, polydispersity index (PDI), zeta potential, and entrapment efficiency. The improved nanoemulsion demonstrated advantageous physicochemical characteristics, including nanoscale droplet dimensions and steady dispersion. The optimized nanoemulsion was integrated into a biocompatible gel matrix, resulting in a nanogel with improved stability and regulated drug release properties. The synthesized nanogel was assessed for rheological characteristics, pH, Spreadability, in vitro drug release, and ex vivo skin penetration. The results demonstrated a prolonged release profile and enhanced penetration efficiency, indicating increased transdermal administration of 4-hydroxyisoleucine. Conclusion: The research investigates the synthesis and characterisation of 4-hydroxy isoleucine (4HILCN), a medication of 99% purity. FTIR spectroscopy was used to identify and describe the medication, assess its purity, and conduct quantitative analysis. The medication was formulated using an optimum composition of three mixtures including oil and Smix and water. The nanoemulsion was transformed into a hydrogel for dermal application using Carbopol-934. The uniformity of the compositions remained stable after being transferred into flint-colored glass containers. The ideal pH range for cosmeceutical assessment is 5.0-6.0. Stability experiments indicated no any variation in parameters which are indicative of the instability. In vitro investigation of drug release kinetics shown enhanced solubility and diffusion rates. Ex-vivo permeation experiments demonstrated superior penetration of drug from 4HILCN-NG compared to Neat Formulation gel of drug and 4HILCN-NEO. The research indicates that the nanogel technology serves as a potential transdermal delivery system for Antidiabetic treatment, providing improved bioavailability and patient adherence.
35. RP-HPLC-Based Stability-Indicating Analytical Method for Concurrent Determination of Finasteride and Tadalafil: Development and ValidationTop of FormBottom of Form
Palanisamy M, Dantinapalli V L S, Elumalai S, Syed M A
Abstract
A stability-indicating RP-HPLC method was developed for the simultaneous estimation of Finasteride and Tadalafil using a Symmetry C18 column and an Acetonitrile:0.1% TEA buffer (pH 2.5, 20:80) mobile phase. Detection at 257 nm, flow rate of 1.0 mL/min, and 6-minute runtime ensured effective separation. The method showed linearity from 12.5–75 µg/mL with R² > 0.999, precision with %RSD < 2%, and LOD/LOQ values of 0.60 µg/mL and 2.00 µg/mL. Assay results for the marketed formulation (ENTADFI) showed 100.0% and 100.2% for Finasteride and Tadalafil, respectively. Forced degradation studies confirmed that Finasteride and Tadalafil were susceptible to degradation under acid, alkali, and oxidative conditions, with maximum degradation observed under acidic (14.0%) and oxidative (14.7%) stress for Finasteride, and under alkali (10.8%) and reduction (14.6%) for Tadalafil. Minimal degradation was seen under thermal and hydrolytic conditions
36. Synthesis of Chitosan Based Nanocomposite with 3-(2-(3,4-dimethoxyphenyl)-2-oxoethylidene) indolin-2-one (RAJI) for Efficient Therapy Against Triple Negative Breast Cancer
Sivaprakasam P, Purushothaman D, Pandurangan A K
Abstract
Cancer is defined by the unregulated and excessive growth of abnormal cells, eventually leading to the destruction of body tissues. Among various cancer types, breast cancer is notably prevalent in females generally originating in the ducts or lobules forming lumps or tumours and subsequently metastasizing to other regions of the body. The treatment of breast cancer is contingent upon its stage and typically involves surgery, chemotherapy, radiation, hormone therapy, etc. Drugs currently available on the market frequently induce substantial adverse effects, which has prompted the development of innovative therapeutic agents. In this study, we propose the use of a novel compound, 3-(2-(3,4-dimethoxyphenyl)-2-oxoethylidene) indolin-2-one (RAJI), with chitosan to create a nanocomposite for the purpose of developing an effective breast cancer treatment. RAJI-loaded chitosan nanocomposite was synthesized using a high-pressure homogenizer and subsequently characterized to assess their physicochemical properties and drug loading profile. The In-vitro toxicity analyses of RAJI on MDA-MB-231 cells – a Triple Negative Breast Cancer (TNBC) cell line, demonstrated its potent anti-cancer properties. Consequently, we speculate that the efficaciousness of RAJI-loaded chitosan nanocomposite in the treatment of TNBC will be superior to that of other commercially available medicines.
37.
Simple, Rapid, Economic and Stability Indicating Method for Propranolol Hydrochloride and Flunarizine Tablets by RP-HPLC
Mashru C, Somaiya C, Joshi K, Dhalani J
Abstract
Simple, sensitive, precise, accurate, economic, and stability demonstrating high performance liquid chromatography method created and confirmed for the simultaneous evaluation of propranolol hydrochloride and flunarizine in drug substance and combined dosage form. The optimum separation was accomplished on symmetry ODS (75 x 4.6) mm, 5µm stationary phase. The mobile phase consists 550 ml of phosphate buffer pH 2.5 and 450 ml of acetonitrile at isocratic rate of 1.0 ml minute-1. Method was validated at 240 nm and 10µl injection volume. Retention time for propranolol hydrochloride and flunarizine were achieved at 0.8 and 2.4 minutes respectively. The recommended method was linear from 1µg/mL to 7.5 µg/mL for flunarizine and from 2µg/mL to 15 µg/mL for propranolol hydrochloride. The proposed method is able to detect 0.1 µg/mL of both flunarizine and propranolol hydrochloride and able to quantify 0.2 µg/mL of both the drug substance. System suitability, linearity, recovery, filter compatibility, repeatability, intermediate precision, specificity, and solution stability criteria were taken into consideration while validating the recommended method. At the benchtop, the sample solution remained stable up to 40 hours and the standard solution up to 42 hours.
38. Migration of Leachables Amount of Antioxidants and Vulcanizers: Analytical Method Development and Validation for Antineoplastic Drug Injection by HPLC
Gorre Vijaya Chandra, Lakshmi Bavisetti, V D N Kumar Abbaraju
Abstract
An HPLC method for the analysis of leachables amounts of Antioxidants and vulcanizers was developed and validated. The method was developed and validated for quantitation on six targeted Antioxidants and vulcanizers in rubber stoppers of antineoplastic Drug Injection. Methods: The analytical method used to determine the leachableamount of antioxidants (BHT,Antioxidant 1010, Antioxidant 1330, Antioxidant 1076, Antioxidant 168) and vulcanizer(Sulfur) in packaging materials for Melphalan Hydrochloride as Injection 50mg/vial and sterile diluent to Melphalan as Injection 10.00mg/vial by HPLC method. The validation was performed on YMC-Pack ODS-AQ (4.6mm×100 mm, 3μm) chromatographic column at 30 °C, and wavelength is 225nm. Mobile phase A is methanol (100%) and Mobile Phase B is purified water at a rate of flow as 1.50mL/min, and the volume injected as 20.00μL. Gradient was set as 0min 25% and 75%, 2min 25% and 75%,4min 100% and 0%,7min 100% and 0%,9min 25% and 75%,12min 25% and 75%. Results: The validation results of Leachables amount of antioxidants(BHT, Antioxidant 1010, Antioxidant 1330, Antioxidant 1076, Antioxidant 168) and vulcanizer (Sulfur) were linear over the concentration from 0.99 µg/mL to 8.078µg/mL (r = 0. 99) and the recoveries and precision ranged from 96.8% to 100.8% (RSD <10%, n =6). Conclusion:This method has been developed and validated successfully and all the results met the acceptance criteria. Hence this method is suitable for testing of Migration of Antioxidants and vulcanizer Melphalan Hydrochloride as Injection 50.00mg/vial along with sterile diluent for Melphalan as Injection 10mg/vial.
39. Formulation of Extended-Release Tablets using Natural Polymers as Matrix-Forming Agents for Sustained Drug Delivery
Deepali Jadhav, Ranjit S Ambad, Roshan Kumar Jha
Abstract
The oral route remains the most preferred method for drug administration due to its convenience and high patient compliance. However, conventional immediate-release formulations often lead to fluctuating plasma drug levels and require frequent dosing, which can impact adherence and therapeutic outcomes. This study focuses on the formulation and evaluation of extended-release (ER) tablets using natural polymers such as xanthan gum, guar gum, and sodium alginate as matrix-forming agents. These biodegradable and biocompatible polymers offer an eco-friendly alternative to synthetic materials, aligning with current trends in sustainable pharmaceutical development. The tablets were prepared using direct compression, with varying polymer concentrations, for pre- and post-compression parameters, including swelling behavior and in vitro drug release.
40.
32 Factorial Design Approaches for Development, Optimization and Characterization of Artemether Loaded Graphene Oxide Nanocomposites
Harshali Sanjay Jadhav, Gaurav Jain
Abstract
Background: Artemether is antimalerial drug having shorter half-life. Conventional form of Artemether required frequent dosing for better pharmacological effect.Objectives: Recently, graphene oxide-based nano-composition has drawn a lot of attention. The loading of drugs in graphine oxide nanostructure will show delay release behavior.Methods: In this study, graphene oxide, which was produced using Hummer’s technique, loaded with Artemether. The correlation of independence and dependant variables were identified using design of expert software. Response surface methodology was engaged to improve formulation. Prepared Artemether loaded graphine oxide nanocomposite were characterized by employing X-ray diffraction (XRD), entrapment efficiency, Differential scanning calorimetry, Fourier transform infrared spectroscopy (FTIR), and drug release.Results: EE for each of the 13 experiments were from 69.58% to 85.78%. The FTIR spectra indicate the presence of Artemether in graphine oxide nanocomposites. Characteristic endothermic peak of Artemether vanished in thermogram of Artemether in graphine oxide nanocomposites. The crystallinity of Artemether decrease as indicate in the XRD peak. The release profile of the Artemether loaded graphine oxide nanocomposite formulation varied across all batches, ranging from 83.22% to 92.11%.Conclusion: The developed AM in GO nanocomposites were seem to be favorable approche for sustained drug delivery of Artemether .
41. Design, Development and Physicochemical Evaluation of Formulation for Gastroesophageal Reflux Disease
Ghugarkar Prasad Gorakshanath, Kadam Pallavi Kanifnath
Abstract
The present study mainly involves the targeting the gastro intestinal ulcer by using Rabeprazole formulation. In this main strategy contains the formulation and optimisation of Rabeprazole pellet formulation. The stomach is the primary acidic environment in which nearly all drugs that inhibit proton pumps breakdown. The strategy involve is to coat the Rabeprazole pellet formulation with polymer coat which release the formulation in appropriate site only. Pre formulation date of material detected. Compatibility study of drug with selected excipients was analysed by using Fourier Transform Infrared Spectroscopy. Thermal study of the Rabeprazole was analysed by using differential scanning calorimetry instrument. Purity of the Rabeprazole was detected by using different physical and chemical characters as well as by using ultra violet spectrometry. For core pellet formulation of Rabeprazole, Extruder and Spheroniser method was used. After core pellet formulation it was seal coated with Opadry seal coat material. Lastly seal coated pellet of Rabeprazole was coated by using Eudragit polymer for site specific drug delivery. Eudragit inhibits the release of formulation in acidic condition. Evaluation parameters detected on optimised batch. Stability study was performed as per International Council for Harmonisation guideline.
42. Formulation Development and Characterization of Pullulan Based Quetiapine Fumarate Oral Films
Venu Babu Chennupati, Venkata Ramana Murthy Kolapalli
Abstract
Quetiapine fumarate is one of the major FDA approved drug in treatment of schizophrenia. Since this drug was having very low bioavailability of 9% and extensive metabolism in liver, it was selected as a suitable drug candidate for our study. This work’s objective was to formulate quetiapine fumarate oral films as alternate dosage form to tablets. All the formulations composed of pullulan as film forming agent and glycerine as plasticizer. The experimental runs were generated by central composite design using MINITAB. The concentration of polymer (300-350mg) and plasticizer (40-50 mg) were altered with in the design space limits. Solvent casting method was adopted for casting the films. Studies on the compatibility of drug excipients were conducted by FTIR analysis and also the surface morphology was studied by SEM analysis. All the film shows good mechanical properties. The other evaluation parameters like surface pH, film thickness, disintegration time and uniformity of weight were evaluated and found within the acceptable limits. Drug release kinetic data shows that all the formulations follow first order release kinetics. Finally concludes that the developed films are expected to increase patient acceptance and the method was also easily adoptable in large scale industries.
43. Pharmacological Investigations of Corchorus trilocularis and Cressa cretica Medicinal Plant for Hepatoprotective Activity
Purnendra Kumar Gupta, Vivek Chourasia
Abstract
In albino rats that had been exposed to carbon tetrachloride-induced hepatotoxicity, the antioxidantand hepatoprotective properties of the ethanolic extract of Corchorus trilocularis and Cressa Cretica leaves were investigated. Biochemical markers such total protein (TP), total albumin (TA), serum glutamate oxaloacetate transaminase (SGOT), serum glutamate pyruvate transaminase (SGPT), alkaline phosphate enzyme (ALKP), whole blood levels, and bilirubin were estimated in order to determine the level of resistance. In vitro and in vivo lipid peroxidation generated by CCl4 was also inhibited by the extract. Rats exposed to hazardous dosages of ethanol extract in carbon tetrachloride (200 and 400 mg/kg body weight) had notable hepatoprotective effects. The extract’s hepatoprotective properties were evaluated against a conventional dose of silymarin (10 mg/kg body weight IP).
44. Pharmacological Activity of
Manilkara hexandra and
Stereospermum colais Buch Leaves Extract for CNS Disorders in Mice
Amit Kumar Agrahari, Vivek Chourasia
Abstract
Depression is a major mental illness worldwide. It is also difficult to identify patients with multiple stressors. For thousands of years, traditional medicine has used many medicinal plants to treat stress due to their effectiveness, efficacy, and safety. This aimed to screening the anxiolytic effect of ethanolic extracts of Manilkara hexandra and Stereospermum colais Buch leaves in rats such as mice. Anxiolytic activity was evaluated in Swiss albino rats. Leaves of Manilkara hexandra and Stereospermum colais Buch plants are dried and crushed to coarse powder. This method was used for this stress study by using Soxhlet extraction. A phytochemical qualitative analysis of ethanolic extracts of Manilkara hexandra and Stereospermum colais Buch was carried out. Lots of models were used for screening the anxiolytic effect of Manilkara hexandra and Stereospermum colais Buch plant leaves: enhancement plus maze model, social model, light-dark model, and whole plate process. For this purpose hydroalcoholic extract is administered orally400 and 300 mg/kgwere selected respectively, as the anxiolytic standard drug diazepam (2 mg/kg) was used. According to the research results, ethanolic extracts of Manilkara hexandra and Stereospermum colais Buch leaves show anxiolytic activity in reducing aversive fear. Studies have shown that hydroalcoholic extracts of Manilkara hexandra and Stereospermum colais Buch leaves have anxiolytic effects. Data show that hydroalcoholic extracts of Manilkara hexandra and Stereospermum colais Buch leaves have anxiolytic properties compared to control.
45. Utilization of Becalutamide Pertinent to Antiandrogen for Development and Validation – A New Perspective
Nagendrababu RAV, Andrews BSA, V D N Kumar Abbaraju, Garimi Tirumala Jyothesh Kumar, K Nagu
Abstract
A new validated HPLC process is developed to determine Bicalutamide (BIC) in pharma formulation. For this analysis Hypersil ODS C18 100 mm × 4.0 mm, 3µ Column, or equivalent is used as a chromatographic column. Isocratic elution is observed at 1.00ml/min. Water as 70v/v, tetrahydrofuran as 20v/v, and acetonitrile as 10v/v of were used as a mobile phase. Run time was identified at 0.50mL/min to 1.50mL/min. 225nm is the UV detection wavelength. 4.0μl sample is injected into the column. For the Sample, blank, placebo, system suitability run time is measured at a time interval of 16 minutes, and for the diluted regular sample it is 60minutes. ± 2.4 minutes is the approximate retention time is identified to BIC. % R.S.D is calculated. For this drug mean percentage recovery is within the limit. By considering the values obtained, this prospective HPLC is successfully applied to formulations. The waste materials obtained in this process may associates with the environment without intervention, the problems ripple to both the ecosystems as well as communities, which may causes severe environmental and health risks. By considering the environmental concerns the waste products so obtained are subjected to Biological treatment (land farming) to control the hazardous waste if any, regated the both halogenated as well as non-halogenated solvents. This developed process is more simple also is exceptional to that of unalike mechanism which can be used in dose forms of syrup.
46. Formulation and Evaluation of Hecogenin-Loaded Phycocyanin Nanosponges for Treatment of Parkinson’s Disease
Nethakara Naveena, Manjuladevi Kasirajan
Abstract
Parkinsonian disease (PD) is a progressive neurodegenerative disease that needs long-term drug delivery treatment beyond the blood-brain barrier. The objectives of the present study were to synthesize and optimize Phycocyanin nanosponges loaded with Hecogenin into optimality by using biocompatible polymers (PVA /PVP) to improve brain-based drug delivery. The nanosponges were prepared through solvent diffusion, and its optimization process was based upon a Box-Behnken Design. The optimized Run 4 exhibited a protein size (193 nm), zeta potential of the prepared entrapping capsule (-32.2 mV), PDI of 0.12, excellent entrapment efficiency (88.5 percent), and a prolonged release drug (80.5 percent in 24-hour period). FTIR analysis confirmed drug-polymer compatibility, while DSC and XRD analyses revealed the amorphous transformation of Hecogenin, improving solubility and stability. Molecular docking studies showed strong binding affinities of Hecogenin to Parkinson’s-related targets MAO-B and Alpha-Synuclein, with favorable MolDock scores (~−166.93) and confirmed BBB permeability. These findings indicate that Hecogenin-loaded Phycocyanin nanosponges are a promising brain-targeted delivery platform for effective PD management through improved bioavailability and sustained release.
47. Repurposing Ropinirole HCl for Targeting Breast Cancer: Preparation and Characterization of Liposomal Formulation Based on QBD Approach
Sebastine Chinnamma A, Mohamed Zerein Fathima M
Abstract
Breast cancer remains a leading cause of cancer-related mortality worldwide, necessitating the development of novel therapeutic strategies. Ropinirole HCl, a dopamine receptor agonist primarily used for Parkinson’s disease, has shown potential anticancer activity by modulating dopamine receptors, inhibiting angiogenesis, and inducing apoptosis in breast cancer cells. This study aims to formulate and optimize a liposomal delivery system for Ropinirole HCl using the Quality by Design (QbD) approach. A Box-Behnken design was employed to evaluate the effects of lipid concentration, stabilizer concentration, and homogenization speed on critical quality attributes, including particle size, zeta potential, and polydispersity index (PDI). The ideal combination (F12) was 75.8 nm in size, -38.6 mV in surface charge, and 0.559 in PDI, meaning that it is more stable and more suitable as a targeted drug carrier. These findings indicate the fact that liposomal Ropinirole HCl can become an excellent method of breast cancer treatment.
48. Molecular Docking, MD Simulation, and Antiproliferative Activity of Pyridazine Derivatives
Ritik Panwar, Vikash Jakhmola, Supriyo Saha, Sunil Jawla, Ravinesh Mishra
Abstract
Pyridazine derivative showed much diversified activity. Previously 77 pyridazine derivatives were synthesized and evaluated the antihypertensive property. Pyridazine derivatives also showed antitumor and antiproliferative behavior. By kept this idea in mind we repurposed those pyridazine derivatives towards antiproliferation using in silico, and in vitro methods. Molecular docking analysis of pyridazine derivatives against DNA (PDB id: 6BNA) were performed and top4 molecules (R45, R60, R67, R70) were identified based on their docking scores. Then 100 ns MD simulation and MMPBSA analysis of these molecules were performed using GROMACS software. MD simulation data showed good RMSD, radius of gyration, SASA, and hydrogen bond analysis. Pyridazine derivative (R67) showed good simulation behavior with very minimum fluctuation within the receptor. Free binding energy of R67 was (-) 42.683 kJ/mol. R67 showed marked GI50 value against MCF7 cell line using sulphorhodamine assay. Among the pyridazine derivatives Among the synthesized molecules 6-([1,1′-biphenyl]-4-yl)-2-(4-([1,1′-biphenyl]-4-yl)-5-thioxo-4,5-dihydro-1H-1,2,4-triazol-3-yl)-4,5-dihydropyridazin-3(2H)-one (R67) showed best antiproliferative activity with in silico insights.
49. A Prospective Interventional Comparative Longterm Study on the Safety of Canagliflozin and Dapagliflozin Depending on their ADR’s and Glucose Monitoring Parameters in a Tertiary Care Hospital for a Span of One Year
Dhanush Bellapu, Ronald Darwin
Abstract
Introduction: SGLT2 inhibitors have a wide extent of restorative movement and higher chance of hypoglycaemia because of their affront autonomous action in treating type-2 Diabetes. SGLT2 inhibitors have great security and resistance when utilized as monotherapy or in conjunction with other oral hypoglycaemic medicines. Since SGLT2 inhibitors can cause hyperglycaemia, which results in vaginal and UTI contaminations. When compared, Dapagliflozin had higher contaminations. The key issue displayed is that ketoacidosis and that it may take a little time to analyse it. Objectives: A careful comparison of Canagliflozin vs Dapagliflozin in terms of long-term urinary volume, renal function, and metabolic changes suggests that both are effective, but Dapagliflozin may have a slightly safer profile regarding fluid balance and tolerance in vulnerable populations. However, individual patient factors (e.g., baseline renal function, risk of volume depletion) must guide the choice. Research methodology: A Planned Interventional Comparative Ponder conducted among 3452 patients who were conceded to in the General Medicine and Endocrine Departments, Anu Group of hospitals, Vijayawada over 12 months from December 2021 to December 2022. By alluding to the patient’s FBS and PPBS, RFT, HbA1c, BP, and the finding seriousness score of ADR (Adverse Drug Reaction) utilizing Naranjo scale. Results: Patients had most common ADRs after Utilizing Canagliflozin and Dapagliflozin, were Hypotension and Dehydration respectively. Conclusion: We concluded that in Patients had ADRs after utilizing Canagliflozin versus Dapagliflozin where hypotension and dehydration was more common respectively. ADRs in the Control population was weight pick up had the negative impact and Hypoglycaemia was found to be more in the Control population compared to Canagliflozin and Dapagliflozin endorsed bunches. Weight loss had a positive impact on Canagliflozin and Dapagliflozin-endorsed groups.
50. Formulation Optimization of Hydrogel-Based Contact Lenses for Dual-Drug Delivery in Glaucoma Treatment
Vangol Varshitha, Umadevi S
Abstract
Glaucoma is a chronic ophthalmic disorder that necessitates long-term therapeutic management to prevent progressive vision loss. Conventional eye drop formulations suffer from rapid precorneal drug elimination, leading to poor bioavailability and frequent dosing requirements. In this study, hydrogel-based contact lenses were developed and optimized for the sustained dual-drug delivery of Timolol Maleate and Brimonidine Tartrate, two first-line antiglaucoma agents. The formulation was optimized using Box-Behnken Design (BBD), where the effects of HEMA concentration (85-95%), EGDMA crosslinker concentration (0.5-1.5%), drug loading (2-6 mg/mL), and water content (30-50%) were evaluated on key parameters such as swelling ratio, tensile strength, optical transparency, drug release kinetics, and drug retention. The optimized formulation exhibited a swelling ratio of 169.1%, tensile strength of 1.2 MPa, and over 95% transparency, ensuring structural integrity and visual clarity. FTIR and DSC confirmed the compatibility of the drug-polymer system, with no significant chemical interactions observed. In vitro swelling studies demonstrated that higher HEMA content promoted hydration, while increased EGDMA crosslinking reduced water uptake, thereby modulating drug diffusion. The cumulative in vitro drug release study revealed a sustained release profile, with Timolol Maleate and Brimonidine Tartrate achieving 96.25% and 97.42% release, respectively, within 24 hours. Drug release followed First-order, Higuchi, and Korsmeyer-Peppas models, indicating diffusion-controlled, non-Fickian kinetics. This suggests hydrogel-based contact lenses provide sustained drug delivery, reducing dosing frequency and improving compliance in glaucoma therapy compared to conventional eye drops.
51. Strategic Formulation of an
In-Situ Floating Raft System for Improved Hypertensive Therapy via Gastric Retention
Neha Raghuwanshi, Vipul Patel
Abstract
Hypertension continues to be a major global health concern, requiring long-term therapy and consistent patient adherence. Metoprolol Succinate (MS), a β1-selective adrenergic blocker, is widely used for hypertension management. Despite its clinical efficacy, challenges such as a short half-life and variable absorption from the gastrointestinal tract often necessitate frequent dosing, which may affect patient compliance. In-Situ raft-forming systems have emerged as promising gastroretentive drug delivery platforms, offering potential for sustained drug release and prolonged gastric retention—especially advantageous for drugs like MS, which are primarily absorbed in the upper gastrointestinal tract. This study explores the formulation of an In-Situ raft-forming gastroretentive gel for MS using a systematic design approach. Natural polymers such as sodium alginate and isapgol were utilized for their ion-activated gel-forming and swelling properties, which enable the formation of a floating, cohesive gel matrix upon contact with gastric fluid. A 3² factorial design was applied to optimize formulation parameters influencing buoyancy, gel strength, and release characteristics. The developed system aims to maintain gastric residence and provide sustained release of MS on raft-forming drug delivery technologies. This approach offers a formulation-based strategy to potentially reduce dosing frequency and improve therapeutic consistency for antihypertensive treatment.
52. Salivary VOCs as a Diagnostic Marker for OSCC by Gas Chromatography-Mass Spectrometry Analysis: An Observational Study
Gracelin Ranjitha E, Sujatha S, Sreekanth P Kunjumon, Vaishnavi Palaniswamy, Ruchika Choudhary
Abstract
Background: Head and neck carcinoma is the sixth most common malignancy globally, with oral squamous cell carcinoma (OSCC) being the most prevalent subtype. While histopathological examination remains the diagnostic gold standard, it is invasive and time-consuming. Metabolomic profiling, particularly analysis of volatile organic compounds (VOCs), offers a promising non-invasive diagnostic approach.Objectives: To identify and compare salivary VOCs between OSCC patients and healthy controls, aiming to explore their potential as diagnostic biomarkers.Study Design and Setting: A case-control study involving OSCC patients and age- and sex-matched healthy controls.Participants: A total of 75 subjects were enrolled, including 35 histopathologically confirmed OSCC patients and 40 healthy controls.Methods: Unstimulated saliva samples were collected and VOCs were extracted using a ZSM-5/PDMS-coated film. Extracts were condensed with 100 μL methanol, and 1.0 μL aliquots were analyzed using gas chromatography–mass spectrometry (GC-MS). Statistical comparisons were performed using the Chi-square test, with significance set at p < 0.05.Results: Ten VOCs demonstrated statistically significant differences between OSCC and control groups. These included two acids, three alcohols, three ketones, and two alkanes. Notably, butanoic acid, pentanoic acid, and 4-methyl were significantly elevated in OSCC patients (p ≤ 0.001). VOC expression patterns also correlated significantly with age, gender, pTNM staging, and histopathological grade.Conclusion: Salivary VOC profiling using GC-MS reveals distinct metabolomic signatures in OSCC patients. Clinical significance: These findings suggest that specific VOCs may serve as non-invasive biomarkers for early diagnosis, prognosis, and therapeutic monitoring of OSCC.
53. Design, Optimization and Characterization of Mouth Dissolving Orodispersible Films of Irbesartan and Triamterene
Abhijeet Motiwale, Narendra Pratap Singh Sengar
Abstract
Mouth Dissolving Orodispersible Films (ODFs) are thin, flexible films designed to dissolve quickly in the mouth without the need for water. They are a convenient and patient-friendly drug delivery system, especially useful for pediatric, geriatric, and pediatric patients or those who have difficulty swallowing tablets or capsules. Mouth Dissolving Orodispersible Films represent a promising drug delivery platform that combines convenience, rapid action, and improved compliance, making them increasingly popular in modern pharmaceutical formulations. In the present work Mouth Dissolving Orodispersible Films of Irbesartan and Triamterene was formulated, optimized using design expert software and further characterized.
54. Comparative Evaluation of Raft Strength and Thickness in Calcium-Based Alginate Formulations for Gastroesophageal Reflux Disease (GERD) Management
Avinash Bhosale, Manoj Shinde, Varsha Mane, Nikhil Salunkhe
Abstract
One common gastrointestinal ailment that has a main effect on patients’ quality of life is GERD. Raft-forming alginate-based formulations provide a physical barrier against acid reflux, with their efficacy largely dependent on raft strength and thickness. This study aimed to associate raft strength and thickness of six commercially available calcium-based alginate formulations in India to assess their potential effectiveness in GERD management. The study examined six different formulations of antacids that contained sodium alginate (250 mg/5 mL), calcium carbonate (80 mg/5 mL), and sodium bicarbonate (133.5 mg/5 mL): GaviRaft®, InstaRaft®, RanRaft®, RACIRAFTTM, Ranidom® RAFT, and ULGE-RAFTTM. The modified balancing technique was used to evaluate the raft strength, and a calibrated Vernier caliper was used to quantify the raft thickness.Data were collected from three independent experiments. Among the tested formulations, only Ranidom® RAFT and RanRaft® met the British Pharmacopoeia (BP) standard for raft strength (≥7.5 g), indicating superior mechanical integrity. RanRaft® and GaviRaft® exhibited the highest raft thickness compared to other calcium-based alginate formulations, indicating their potential to form a strong physical barrier against reflux.All the formulations met the criteria for assay of sodium alginate as per BP (86-116%), except for Ranidom® RAFT (129.02%). The study found variations in raft strength and thickness among calcium-based alginate formulations, with RanRaft® achieving an optimal balance. These findings highlight the importance of formulation selection in GERD management. Clinical trials are desirable to authorize these in-vitro results and assess patient outcomes.
55. Development of Novel Nanofiber Patches Loaded with
Boerhavia diffusa Root Phytochemicals for Enhanced Wound Healing: A Response Surface Methodology Approach
Smita Borkar, Prashant Kumar Dhakad, Hemant Kumar Singh Yadav
Abstract
This research focuses on the development and optimization of a novel nanofiber patch loaded with Boerhavia diffusa root extract for enhanced wound healing by Response Surface Methodology (RSM) method. Boerhavia diffusa, a traditional medicinal plant, is known for its wound healing properties through stimulation of angiogenesis, collagen formation, and epithelialization. The methanolic extract was incorporated into polyvinyl alcohol (PVA) and polyethylene oxide (PEO) solutions at 8 mg/mL concentrations and electrospun into nanofiber mats under optimized conditions. The study employed a 32 factorial design using RSM with Design Expert-7 for evaluating drug entrapment efficiency and swelling index. Characterization techniques were applied to analyze nanofiber’s morphology, structural properties, thermal behavior, and crystallinity. The optimized batch (BDRNF7) demonstrated 85.12% drug entrapment efficiency, uniform thickness, and sustained drug release. Additionally, chitosan/alginate membrane dressings were synthesized through physical blending and covalent crosslinking to evaluate film uniformity, mass, pH, and drug content. BDRNF7 showed significant wound contraction, enhanced skin breaking strength, and effective wound healing compared to controls. Moisture interaction studies indicated the patch’s stability under varying humidity. Statistical analysis confirmed the model’s significance (F-value: 11.88, Adjusted R²: 0.8718). In conclusion, the developed nanofiber patch exhibited potential as a bioactive wound dressing, providing effective drug delivery and accelerated wound healing. Further studies will validate its clinical application in wound care management.
56. Formulation and Evaluation of Fexofenadine hydrochloride-Nutraceutical Cocrystal to Improve Bioavailability through Inhibition of P-Glycoprotein Mediated Drug Efflux
Arpana Patil, Shubham Biradar, Nitin Khandagale, Vishal Zambre
Abstract
Background: Pharmaceutical co-crystallization is recommended as novel approach to improve bioavailability of BCS class-III drugs. Fexofenadine HCl (FEX) is an antiallergic, exhibits low oral bioavailability (33%). FEX being a substrate of p-gp drug efflux transporter which is accountable for its poor bioavailability. Drug-Nutraceuticals co-crystallization is projected as a rationale approach to improve the permeability of FEX. Coformers having ability to inhibit p-gp were screened by molecular docking approach. Additionally, the coformers were also looked up for the nutritional value they offer. Co-crystals of FEX with Piperine (FEX-PIP) and Curcumin (FEX–CUR) were effectively developed by NG &LAG method. Molecular docking studies revealed the possibility of one hydrogen bond with -4.5 Kcal/mol binding affinity of FEX with Curcumin. FEX–CUR (1:1) cocrystals characterized by SEM, FTIR, DSC &P-XRD. Cocrystal contained O-H-O hydrogen bond amid oxygen atom of secondary -OH of FEX and hydrogen atom of para-hydroxy group on aromatic ring of CUR. The permeability of newly formed cocrystals evaluated by everted gut sac method displayed a 2.68-fold increase in permeability as matched to drug and 2.62-fold increase in dissolution profile. Results indicated usefulness of cocrystallization method to expand permeability of FEX using nutraceuticals as coformers.
57. Exploring Locust Bean Gum and Thiolated Chitosan Hydrogels for Sustained Delivery of Telmisartan in Hypertension Treatment: An
In Vivo Study
V Mohanraj, M Komala
Abstract
This article outlines development of a mucoadhesive hydrogel composed of thiolated chitosan and Locust Bean Gum for targeted transport of telmisartan. Hydrogel was prepared by tri-polyphosphate ionotropic gelation cross-linking method. Optimized formulation was evaluated in a preclinical study using a hypertension-induced rat model, comparing it to free telmisartan. Research showed that oil-entrapped beads loaded with TEL had a relative bioavailability of 151.59%, 1.52 times greater than the pure TEL suspension. It appears that the new method of drug delivery using oil-entrapped beads loaded with transdermal ligands improves patient compliance by increasing drug solubility, oral bioavailability, and therapeutic effectiveness. Further, the formulation’s anti-hypertensive effects were verified to be substantially prolonged in animal models by in vivo pharmacodynamic tests.
58. pH and Enzyme Responsive Enteric Coated Systems for Targeted Delivery of Probiotics to Colon
Ramesh Ingole, Amol Landge, Ganesh Nigade, Sachin Nitave
Abstract
The effectiveness and precise delivery of probiotics are essential for their therapeutic benefits, especially for strains like Lactobacillus rhamnosus GG, which need to endure the tough conditions of the gastrointestinal tract to reach the colon. This study usual out to form and evaluate a new dual-layer enteric-coated system that combines a pH-sensitive outer layer (Eudragit® L 100) with an enzyme-responsive inner layer (Pectin/Resistant Starch) to improve colonic delivery. Scanning Electron Microscopy (SEM) showed that the coatings were smooth, continuous, and durable. In vitro tests revealed that this combined system maintained 88.5% probiotic viability after 2 hours in simulated gastric fluid and 80.2% viability after 4 hours in intestinal fluid, significantly better than uncoated and single-layer-coated options. In simulated colonic fluid, the dual-coated system achieved an impressive 84.0% cumulative release and a peak viable count of 5.2×10⁹ CFU/mL at the 12-hour mark. Stability tests indicated a 75.0% retention of viability subsequently 6 months at 25°C/60% RH, with strong viability preservation at 4°C for a full year. These results highlight the dual-responsive system’s ability to protect probiotics during their journey through GI tract and facilitate targeted release in colon, showcasing its promising potential for enhancing probiotic therapies and functional food applications.
59. Integrative Approaches in Hypertension Management: A Review of the Combination of Allopathic Drugs and Herbal Medicines in Drug Delivery Systems
Shital A Shinde, Dipak P Mali, Vandana M Thorat, Ankita D Walgude
Abstract
Hypertension remains an important worldwide fitness distress, requiring development of integrative medicinal approaches to improve action outcomes. This review explores the synergistic combination of allopathic antihypertensive drugs and herbal medicines within drug delivery systems (DDS) to improve efficacy, minimize adverse effects, and optimize patient adherence. By leveraging modern DDS technologies such as controlled-release systems, nano formulations, and liposomes, the bioavailability and targeted delivery of both pharmaceutical and herbal compounds can be significantly enhanced. The review begins by discussing the global impact of hypertension, highlighting the need for complementary therapies and defining the concept of allopolyherbal formulations. It then examines the pharmacological mechanisms of conventional antihypertensive drugs and herbal medicines, focusing on their potential for synergistic interactions. The role of DDS in addressing challenges related to bioavailability is explored, with emphasis on nanotechnology, polymeric carriers, and targeted drug delivery. The clinical efficacy and safety of combining allopathic and herbal medicines are reviewed, incorporating recent clinical trial evidence and safety considerations such as herb-drug interactions, standardization issues, and regulatory challenges. Furthermore, the application of allopolyherbal formulations in hypertension management is assessed, with discussions on future trends, including personalized medicine and smart drug delivery systems. The review concludes by emphasizing the importance of integrating advanced pharmacovigilance frameworks and evidence-based regulatory strategies for assured of safety as well as efficient adoption of formulations. By addressing key pharmacological, technological, and regulatory aspects, this integrative approach offers a promising strategy to enhance hypertension treatment and patient outcomes.
60. Recent Advances in the Formulation of Microspheres for the Effective Treatment of Rheumatoid Arthritis
Mahua Bera, Suman Pattanayak, Sovan Pattanaik
Abstract
Rheumatoid arthritis (RA) is an autoimmune disorder requiring targeted and sustained therapeutic interventions. Microspheres have emerged as a promising drug delivery system for rheumatoid management, offering improved bioavalability, reduce toxicity and enhance patient compliance. Recent advances in microspheres formulation have focused on developing biodegradable and biocompatible microspheres using natural and synthetic polymers. Novel fabrication technique such as microfluidics, electrospray and 3D printing has enabled the creation of uniform microspheres with controlled size, shape and composition. Additionally surface modification strategies have been explored to enhance microsphere targeting and cellular uptake. This abstract reviews the recent advances in microspheres formulation for RA management highlighting the potential of these systems to improve therapeutic outcomes and patient quality of life.
61. Green Silver Nanoparticles: A Comprehensive Review of Synthesis, Characterization, and Applications
Ashwini M Bhurre, Pratibha Dawaande, Anita Wanjari
Abstract
An eco-friendly substitute for traditional methods is herbal green synthesis, which produces silver nanoparticles (AgNPs) from plant extracts. The methods used to characterize the nanoparticles are examined in this review, including FTIR, TEM, XRD, and UV-Vis spectroscopy. The study emphasizes how herbal green AgNPs can be used for antibacterial, anticancer, and environmental remediation purposes. Scalability, uniformity, and toxicity evaluations present difficulties nonetheless. Studies on plant sources and sophisticated characterization techniques ought to be the main areas of future investigation.
62. Antimicrobial Resistance (AMR) to Antibiotic Therapy: An Emerging Healthcare Crisis for Treating Infective Diseases
Ashwini M Bhurre, Pratibha Dawaande, Anita Wanjari
Abstract
The worldwide healthcare system is facing an increasing danger from antimicrobial resistance (AMR), which is influencing antibiotic treatments and driving up healthcare expenditures. Examining the causes, progression, and mechanisms of resistance, the research highlights the need for innovative treatments, novel antibiotics, infection prevention, stewardship initiatives, and global monitoring. In order to combat AMR and guarantee the efficacy of antibiotics, cooperation between governmental bodies, healthcare providers, and academic institutions is essential.
63. Invasomes : A Novel Transdermal Approach for Antifungal Drug Delivery
Shivaji Patil, Sushil Bhargav
Abstract
Management of fungal infections, for those affecting skin, has faced challenges in poor penetration and efficacy. Traditional topical antifungal therapies often show limited results due to the skin’s barrier properties. Invasomes, has emerged as a greater tactic to improve drug penetration through skin, improving penetration and effectiveness of antifungal drugs. This review comprehensively analyzes invasomes as a transdermal drug delivery system specifically for antifungal therapies. It covers structure, composition, and mechanism of action of invasomes, Focusing on their advantages over conformist drug delivery systems. Key factors influencing invasome efficacy, such as the incorporation of phospholipids, ethanol, and terpenes, are discussed in detail. Invasomes significantly improve drug permeation through skin due to their flexible lipid bilayer structure and presence of ethanol and terpenes, which disrupt skin’s lipid matrix. Various studies have demonstrated the potential of invasomes in delivering antifungal drugs more effectively than conventional topical formulations. The increased drug bioavailability and improved therapeutic outcomes underscore the utility of invasomes. Invasomes characterize a capable transdermal delivery system for antifungal drugs, offering improved drug permeation, stability, and therapeutic efficacy. Their ability to overcome the skin barrier makes them an alternative to traditional topical formulations.
64. Analytical Strategies for Stability-Indicating Method Development: Challenges and Advances in Fixed-Dose Combination Formulations
Neelakshi Tendulkar, Mohammad Asif
Abstract
Stability-indicating methods (SIMs) in the pharmaceutical industry are critical to guaranteeing product safety, efficacy, and compliance with regulatory requirements, especially for fixed-dose combination (FDC) formulations. The review addresses both advancements and challenges in SIMs by confronting the tremendous complexities posed by the presence of multiple active pharmaceutical ingredients (API) and their degradation pathways. The review surveys some works in which degradation products were investigated using traditional and novel methods, from HPLC, UHPLC, and HPTLC to spectroscopic techniques, on to the hyphenated techniques of LC-MS and GC-MS. The concepts of forced degradation and regulatory input found great emphasis along with advances such as AI-driven optimization, green chemistry, and real-time stability monitoring. Directions for future studies focus on implementing automation, environmentally-friendly methods, and hybrid techniques in a way that maximizes efficiency and viability and aligns with a rapidly changing regulatory environment. Therefore, this review underlines the need for robust, specific, and cost-effective SIMs to guarantee the long-term stability of FDC formulations.
65. Phytonanoformulations as New Frontier in Effective Management of Diabetes Mellitus Type 2
Nagineni Sudarshan Rao, P Balaji
Abstract
The chronic metabolic disease known as type 2 diabetes mellitus (T2DM) is typified by β-cell dysfunction, insulin resistance, and poor glucose metabolism. Despite the availability of pharmacological treatments, many patients experience inadequate glycemic control and adverse side effects. Recent developments in nanomedicine, especially the application of phytonanoparticles (PNPs), have demonstrated potential as a cutting-edge strategy for the treatment of type 2 diabetes. Phytonanoparticles are plant-based nanoparticles with special qualities like low toxicity, biocompatibility, and antioxidant activity that make them excellent options for treating diabetes. Phytonanoparticles exhibit several mechanisms of action that can address key aspects of T2DM. Their antioxidant and anti-inflammatory qualities aid in lowering oxidative stress, which is a major contributor to the etiology of type 2 diabetes. Additionally, PNPs may promote β-cell function, control glucose homeostasis, and improve insulin sensitivity. Additionally, phytonanoparticles can facilitate the targeted delivery of therapeutic agents, minimizing side effects and improving drug bioavailability. This review explores the synthesis, characterization, and therapeutic potential of phytonanoparticles in T2DM treatment. Various plant sources, such as Curcuma longa (turmeric), Azadirachta indica (neem), and Allium sativum (garlic), have been explored for their ability to produce nanoparticles with anti-diabetic properties. Furthermore, we discuss the mechanisms through which PNPs exert their beneficial effects, including modulation of inflammatory pathways, enhancement of insulin signaling, and reduction of hyperglycemia. Although research on PNPs in T2DM is still in its early stages, the results to date suggest that they hold significant potential as adjuncts to conventional treatments, offering a safer, more effective therapeutic option for managing T2DM. Phytonanoparticles represent a promising frontier in diabetes therapy, combining the power of plant-based compounds with nanotechnology to offer a multi-targeted approach to combat Type 2 diabetes mellitus.
66. Revolutionizing Quality Assurance with Artificial Intelligence Technology
Hiralben Mehta, Ratna Purvang Musale, Patel Ayushi Shaileshbhai
Abstract
Today, Artificial Intelligence within the space of only more than a couple of decades, is transforming rapidly a whole array of industries-quality assurance cannot be one exception. Through changing the very terrain of Quality assurance by way of mechanization and adding newer dimensions to the old approach of testing, Artificial Intelligence indeed is a much significant influence factor on this review. We will discuss the applied Artificial Intelligence applications in Quality assurance that are used for test case generation, test automation, and defect prediction, among other uses. The use of Artificial Intelligence algorithms helps Quality assurance teams optimize their workflow, predict issues at an earlier development cycle, and deliver more reliable software. However, applying Artificial Intelligence in Quality assurance faces several challenges, such as low data quality, model interpretation, and the need for high-level Artificial Intelligence professionals. This Article aims to provide insightful ideas for both professionals and researchers in exploiting the potential of Artificial Intelligence for optimizing Quality assurance strategies to achieve the best results for the software product developed.
67. Advancements in Solubility and Bioavailability of Calcium Channel Blockers: A Comprehensive Review
Meor Mohamad Nurhakim Meor Mohd Redzuan, Mohd Zamir Rusydi bin Zamri
Abstract
The present review addresses the challenges associated with the low aqueous solubility of Active Pharmaceutical Ingredients (APIs) focusing specifically on Calcium Channel Blockers (CCBs). These drugs are classified as Class II compounds in the Biopharmaceutical Classification System (BCS), characterised by high permeability but limited bioavailability. This low bioavailability constrains the therapeutic efficacy of CCBs as antihypertensive agents. Research efforts concerning solubility enhancement and modification of bioavailability of CCBs, dosage forms and their physicochemical properties pharmacokinetics are presented. This paper presents the latest updates and techniques in drug formulation, enabling researchers and formulators to develop strategies to address solubility issues and, hopefully, improve therapeutic indices in patients.